BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,MCOL MG,4.7MM,10M

    MDR report key: 25159977 · Received May 13, 2026

    Report

    Report Number
    0001038806-2026-02635
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 13, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019775
    PMA / PMN Number
    K111889
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). E1: LAST NAME UNKNOWN / NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER K101880.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH #18 LOST INTEGRATION DUE TO PERIIMPLANTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245448 IMP,TSV,MCOL MG,4.7MM,10M DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1277744 00889024019775

    Patients

    Seq Age Sex Outcome Treatment
    1